Revolutionising cancer treatment: The promise of point-of-care CAR-T therapy

CAR-T cell therapy, a groundbreaking approach that genetically modifies patients’ T-cells, offers a targeted and effective means of combating cancer cells. Traditionally, CAR-T manufacturing has been confined to highly specialised laboratories, primarily in Western nations, resulting in prohibitive costs for many Indian patients. To address this challenge, promoting local manufacturing of CAR-T cells, aligned with the “Make in India” initiative, can significantly reduce expenses, streamline logistics, and ensure timely treatment for a broader population.

Advanced cell therapy technologies tailored to local needs

Successful implementation of CAR-T cell therapy in India necessitates the adoption of cell therapy technologies that cater to local requirements. Given the country’s diverse population and unique healthcare landscape, innovative approaches, such as cost-effective and scalable manufacturing processes, are paramount to meeting the substantial demand. Establishing local production facilities equipped with state-of-the-art, internationally recognised technologies ensures that top-quality CAR-T cell therapies reach patients nationwide, including those in remote and underserved regions.

Point-of-care (PoC) manufacturing effectively tackles the current limitations of CAR-T therapy:

• Broadened patient access: Local manufacturing of CAR-T cells expands patient access, particularly in a country like India, where high costs render these global therapies unaffordable.
• Cost reduction: PoC manufacturing lowers production and treatment expenses compared to centralised facilities in Europe or North America, making CAR-T therapy more economically viable.
• Expedited treatment: It reduces vein-to-vein time, enabling faster treatments without the need for bridging therapy, thereby improving patient outcomes.
• Enhanced physician involvement: Treating physicians can actively participate in the process, thus tailoring therapies more precisely to individual patient needs.
• Streamlined logistics: PoC manufacturing eliminates numerous logistical complexities associated with transporting cells across continents, enhancing treatment efficiency. Even if CAR-T cells are produced locally in a central facility in India, the country’s vast size poses logistical challenges in terms of timely transportation and temperature maintenance.
• Rare indications: PoC manufacturing opens avenues for exploring treatments for rare immunity-related conditions beyond cancers, particularly relevant for paediatric patients.

Ensuring quality and patient safety in PoC settings

Maintaining consistent quality and patient safety across diverse PoC sites involves several key strategies:

• Closed and automated systems: Employing fully integrated, automated, and closed systems minimises contamination risks and ensures product consistency. These systems also mitigate the likelihood of patient material mix-ups and meet stringent quality control requirements.
• Standardisation and process control: Implementing standardised manufacturing protocols and quality control testing guarantees that all PoC sites generate comparable data and uphold high standards.
• GMP facilities: Establishing Good Manufacturing Practice (GMP) facilities with advanced equipment and skilled personnel is essential. These facilities must adhere to rigorous regulatory requirements to ensure product quality and safety.
• Automation and innovation: Leveraging automated manufacturing platforms, such as the CliniMACS Prodigy, enhances efficiency, reduces costs, and enables decentralised production in various settings, including academic, non-profit, and even for-profit entities. This makes CAR-T therapy feasible and accessible in developing nations like India.

Point-of-care CAR-T cell manufacturing holds immense potential to revolutionise cancer treatment by increasing patient access and reducing costs. While challenges exist, such as the need for GMP infrastructure, trained personnel, and regulatory approvals, solutions like integrated, automated manufacturing platforms can effectively overcome these hurdles. By harnessing local expertise and fostering international collaboration, India can emerge as a leader in providing affordable, high-quality CAR-T therapies, ensuring that life-saving treatments reach cancer patients across the nation.